Lunesta Starting Dose Cut to 1-mg Due to Next-Day Sleepiness

May 15, 2014 — The U.S. Food and Drug Administration (FDA) recommends that doctors should lower the starting dose of Lunesta, a popular sleeping pill, to 1-mg.

The problem is that Lunesta can cause next-day sleepiness. This can impair driving ability, memory, and coordination.

In a study of 91 healthy adults between the ages of 25 and 40 who took 3-mg of Lunesta, impairment was worst 7.5 hours after the first dose, and was still present 11.5 hours later.

In many cases, patients reported that they did not feel drowsy, but tests proved that they were actually impaired. This is concerning from a public safety standpoint. The FDA has already warned that patients on the 3-mg dose of Lunesta should not drive, engage in hazardous activities, or perform tasks that require complete mental awareness the following day.

According to Dr. Ellis Unger, director of the FDA Office of Drug Evaluation:

“To help ensure patient safety, health care professionals should prescribe, and patients should take, the lowest dose of a sleep medicine that effectively treats their insomnia.”

The new warnings for Lunesta come almost exactly one year after the FDA made similar warnings for Ambien (zolpidem). The FDA explicitly warned about next-day impairment for women and those taking extended-release versions of Ambien. For Lunesta, men and women had similar rates of impairment. The FDA recommended that all patients should be started on the 1-mg dose.

Do I have a Lunesta Lawsuit?

The Schmidt Firm, PLLC is currently accepting Lunesta induced injury cases in all 50 states. If you or somebody you know has been injured in a car accident or other consequence of next-day sleepiness, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.

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